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Sr. Clinical Research Associate

3-4 years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: \B.Pharm/M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

📌 Sr. Clinical Research Associate | Sun Pharmaceutical Industries Ltd - Gurgaon, R&D
📍 Location: Gurgaon, India
💼 Company: Sun Pharmaceutical Industries Ltd
🕒 Experience: 5+ years in Clinical Research

Role Overview

The Sr. Clinical Research Associate (CRA) will be responsible for overseeing the full scope of clinical trials, ensuring adherence to study protocols, regulatory requirements, and ethical standards. This role involves end-to-end site management, training and mentoring, site monitoring, and effective communication with cross-functional teams.

Key Responsibilities

Study Management: Ensure clinical trials are conducted at sites in compliance with protocols, local regulatory requirements, ICH GCP, and ethical standards.
Site Communication: Act as the primary point of communication between Sun Pharmaceutical and clinical trial sites.
Regulatory Submission & Feasibility: Support regulatory submissions, perform site feasibilities, and ensure sites are prepared for submissions and approvals.
Site Selection & Visits: Identify, plan, and conduct site selection visits, and follow up on site actions.
Training & Mentoring: Provide training to CRA teams, conduct SIVs, and ensure site teams are up-to-date on study documents, processes, and amendments.
Monitoring Visits: Plan and conduct onsite monitoring visits as per the monitoring plan, and follow up on open action items.
Risk & Recruitment Management: Manage site recruitment strategies and address study risks proactively.
Audit & Compliance: Ensure site readiness for audits, inspections, and quality visits, and manage site closure visits.
Cross-Functional Collaboration: Collaborate with cross-functional teams (e.g., Quality, Data Management, Medical Teams) for efficient study execution.
Budget & Invoice Management: Negotiate study budgets with sites and ensure timely payment processing according to Clinical Trial Agreements (CTAs).
Outsourced Trials: Ensure quality oversight of CRO-monitored sites, share observations, and ensure corrective actions are implemented.

Qualifications

🎓 Education:

  • Pharmacy Graduate (4 years) or Post Graduate in Pharmacy or other related fields.

💼 Experience:

  • 5+ years of experience in clinical research, with 3-4 years of onsite monitoring experience for Phase II/III global trials.

Desired Skills

  • Strong understanding of clinical trial protocols and regulatory requirements.
  • Excellent communication and interpersonal skills for effective site management.
  • Mentorship capabilities to train and support CRA teams.
  • Ability to manage site recruitment strategies and address recruitment risks.

Benefits & Work Conditions

  • Full-time position with frequent travel.
  • Competitive compensation and benefits.
  • Presence at work required.

📩 Apply Now